Serological Screen and Treat Trial for Plasmodium Vivax
NCT ID: NCT04223674
Last Updated: 2023-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1133 participants
INTERVENTIONAL
2022-02-09
2023-12-30
Brief Summary
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Detailed Description
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After obtaining informed consent from their parents/legal guardians, 800 schoolchildren living in Batubara regency, North Sumatra, Indonesia, will be individually randomized to intervention (SSAT) or control (routine care) group. During enrollment, all participants will be tested with Pv serological test by standard Luminex, and standard finger stick microscopic. Their hemoglobin (Hb) and Glucose-6-Phosphate Dehydrogenase (G6PD) level will be measured. Children with Hb level\<9 g/dL and/or G6PD \<4 U/g Hb (male) or \<6 U/g Hb (female) will be excluded. In the intervention arm (SSAT), children who are seropositive by standard Luminex and/or symptomatic LMF positive will be treated with dihydroartemisinin-piperaquine (DHA-PP) for 3 days according to national guideline and primaquine/PQ high dose (1 mg/kg BW/day for 7 days for Pv/Po, 0.25 mg/kg BW for Pf). In the control arm, children will be treated only when they show symptoms (body temperature\>=36.5oC or history of fever within last 3 days) and proven positive by LMF. All treatment will be provided under direct supervision by the research team during which any adverse event/severe adverse event will be recorded. Hemoglobin level and urine will be monitored daily for 7 days of PQ administration. Post-hoc qPCR detection will be performed to determine their initial malaria status. Several additional tests will also be performed to all participants during this initial screening: microscopic examination of shallow vasculature of the ankle (light microscopy-skin/LMS), magneto-optical detection of hemozoin, and post-hoc point-of-care/POC serological test.
After enrollment, all children will be actively followed for 9 months every 4 weeks for post-hoc assessment by qPCR. Anytime during this follow up period, children becoming acutely ill will be tested for malaria by LMF, and referred to Primary Health Center to receive treatment when positive. Furthermore, household members of these infected children will also be screened for malaria infection by LMF and post-hoc LMS and qPCR. This family screening will be performed by 2x house visit (7-10 AM and 7-10 PM). Treatment will be given for those found positive by LMF regardless of their symptoms. Antimalarial treatment provided during this follow up period will be according to national standard guideline: 3 days of DHA-PP plus PQ (single 0.25 mg/kg BW dose for Pf, daily 0.25 mg/kg BW dose for 14 days for Pv/Po).
At the end of study, Pv serological test and LMF will be performed to all schoolchildren. Those found positive by LMF will be referred to Primary Health Center to receive treatment according to national standard guideline.
Sponsor: WEHI, Funding: NHMRC, Grant number: GNT1102297
Conditions
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Study Design
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RANDOMIZED
PARALLEL
960 children living in western Indonesia will be individually randomised to the experimental serologic test or routine care.
Children in the serological diagnosis arm will be screened for the presence of antibodies to a previously validated panel of malaria antigens optimized for sensitivity to infection during the prior 9 months. Furthermore, they also will be screened by microscopy. If positive by either test, they will be treated for that malaria infection.
Children assigned to routine care will be screened by microscopic examination and treated when they show or have history of symptoms in the last 3 days.
After initial screening and treating according to diagnostic technique, all children will be actively followed for 9 months with PCR detection every 4 weeks.
SCREENING
NONE
Study Groups
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Serological screen and treat
Children who screened with sero test and microscopy. A 7-day high dose PQ will be provided for those with Pv seropositive regardless of their symptoms and symptomatic children with microscopic Pv/Po positive.
Serological screen and treat
Multi-antigen sero-diagnostic test for measurement of P. vivax antibodies in plasma from finger stick as a means to detect hypnozoite carriers for treatment
Routine care
Children who screened with sero test and microscopy. A 7-day high dose PQ will be provided only for symptomatic children with microscopic Pv/Po positive.
No interventions assigned to this group
Interventions
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Serological screen and treat
Multi-antigen sero-diagnostic test for measurement of P. vivax antibodies in plasma from finger stick as a means to detect hypnozoite carriers for treatment
Eligibility Criteria
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Inclusion Criteria
* no evidence of health condition that would interfere with study participation
* assent of child and documented parental informed consent
Exclusion Criteria
* Haemoglobin \< 9 g/dL
6 Years
15 Years
ALL
Yes
Sponsors
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Eijkman Institute for Molecular Biology
OTHER
Oxford University Clinical Research Unit Indonesia
OTHER
Walter and Eliza Hall Institute of Medical Research
OTHER
Rumah Sakit Umum Daerah Mimika
UNKNOWN
Universitas Sumatera Utara
OTHER
Indonesia University
OTHER
Responsible Party
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Inge Sutanto
Professor
Principal Investigators
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Inge Sutanto, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Indonesia University
Locations
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Tanjung Tiram Primary Health Center
Tanjung Tiram, Batubara, Indonesia
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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19-09-1129
Identifier Type: -
Identifier Source: org_study_id
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